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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K073415
Device Name NEMUS SYSTEM; NEMUS PC PERIPHERAL
Applicant
EB NEURO, S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL,  IN  46032
Applicant Contact Allison Scott
Correspondent
EB NEURO, S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL,  IN  46032
Correspondent Contact Allison Scott
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
GWF   GWJ   JXE  
Date Received12/04/2007
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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